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Boston Scientific recalls INGENIO family of pacemakers, CRT-Ps 

The FDA has identified this as a Class I recall, the most serious type of recall and use of these devices may cause serious injuries or death.

Boston Scientific is recalling INGENIO family of pacemakers and CRT-Ps due to the risk of transitioning to safety mode. Safety mode is intended to provide backup if the device is faulty. However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device goes into safety mode, the device cannot be reprogrammed and must be replaced.

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The use of the affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life-threatening injury (for example, need of temporary pacing where a healthcare provider delivers controlled electric pulses to pace a heart), worsening of heart failure and death.

There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing. There have been no reports of death.

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